About this trial
The ultimate goal of this research is to optimize care for patients undergoing laparoscopic bariatric surgery while alleviating pressure on hospital resources and staff. Furthermore, the study aims to generate policy-relevant data that can inform policymakers and healthcare providers in developing funding models and care pathways that balance safety, efficiency, and cost-effectiveness. This could support a broader implementation of ambulatory bariatric surgery without compromising quality of care.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18-65 years old
Undergoing scheduled ambulatory Roux en Y Gastric Bypass
ASA score I or II
Competent to provide informed consent
Disqualifiers
Presence of coagulation abnormalities or use of anticoagulant therapy
History of major abdominal surgeries, including laparotomy
Absence of informed consent or request not to participate in the study
Trial design
Parallel
Treatments tested in this trial
remote clinical monitoring
DeviceRemote clinical monitoring after same day discharge
Control group
Other interventionControl group with overnight stay in hospital
Treatment groups
Trial outcomes
Primary outcomes
Feasibility of same day discharge with a remote monitoring pathway
The primary outcome of this study is to assess the feasibility of a SDD care pathway with remote monitoring for patients undergoing laparoscopic RYGB in an ambulatory setting.
cost-effectiveness analysis
). The CEA will result in an incremental cost-effectiveness ratio (ICER), which is the ratio of the incremental costs of the remote monitoring program to incremental health gains of the program compared to the standard care. The analysis will be performed from a societal perspective, meaning that all relevant costs will be included, irrespective of who pays for the costs (patient, hospital, or RIZIV).
Secondary outcomes
Clinical safety- complications
Postoperative complications will be classified using the Clavien-Dindo classification system and assessed up to 3 months postoperatively.
• Patient Quality of Life
o Evaluated using the EQ-5D questionnaires. * In the intervention group, patients will receive these questionnaires digitally through the BeWell application. The frequency of questionnaire administration will be increased to daily during the first 7 postoperative days, and subsequently at 2 weeks, 1 month, 6 weeks, 2 months, and 3 months after surgery (17,18). * In the control group, questionnaires will be administered in person during their hospital stay or by telephone after discharge. Questionnaires will be administered at 1 day, 7 days, 1 month, 2 months, and 3 months after surgery.
• Patient Satisfaction
Patient Satisfaction will be measured after 3 months using a 7-point Likert scale and 11-point Numeric Rating Scale (NRS 0-10) to assess satisfaction with the care pathway, feelings of safety, and sufficiency of recovery advice/follow-up information
Length of stay
o Duration of Hospital Stay: The total number of hours from surgery to discharge will be recorded, with hospital admission and discharge data systematically collected for both groups.
Sponsors and contacts
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